Morning Briefing
Summaries of health policy coverage from major news organizations
Only Branded Companies Can Market Drugs For Off-Label Use Now But Two Senators Want To Change That
Stat: New Bill Would Grant FDA Power To Add Off-Label Uses To Generic Drug Labels
A bipartisan duo of senators wants to give the Food and Drug Administration the power to add off-label uses to certain generic drug labels. Sens. Orrin Hatch (R-Utah) and Michael Bennet (D-Colo.) introduced legislation late Thursday that would put in place new requirements on generic drug makers and FDA. (Florko, 9/28)
In other pharmaceutical news —
Stat: Regeneron Tries To Elbow Its Way Into Crowded Immunotherapy Market
Regeneron Pharmaceuticals (REGN) has won Food and Drug Administration approval for a new cancer therapy, lining up behind five marketed treatments that work by removing brakes on the immune system to turn the body’s defenses against tumors. The company, alongside partner Sanofi (SNY), is entering a crowded market in which it is years behind the leaders, who have reaped billions of dollars in sales while racking up FDA approvals in more than a dozen tumor types. But Regeneron believes that, with some clever positioning and combination treatments, it can outfox its rivals and build its drug, cemiplimab, into a contender in the field. (Garde, 9/28)
The Star Tribune: UnitedHealth's OptumRx To Combine With Pharmacy Services Firm In $2B Deal
The nation’s largest insurance company confirmed Friday that its OptumRx division for pharmacy services is combining operations with Genoa Healthcare, a company that runs more than 425 pharmacies in behavioral-health centers in 46 states. ... UnitedHealth has said that transforming pharmacy care services is a key goal it hopes to accomplish by applying its growing expertise in clinical affairs, technology and data analytics. (Carlson, 9/28)
